About the role

Associate Medical Director ensuring oncology trial medical and safety integrity. Supporting biopharmaceutical clients through medical monitoring, regulatory review, and clinical study oversight.

Responsibilities

Provide independent medical monitoring support for assigned clinical studies, respond to medical inquiries, assist with protocol interpretation and medical review of data to ensure protocol adherence, consistency and scientific validity of the data
Assist the project manager in client discussions regarding safety-related questions or concerns
Prepare medical monitoring plans and other relevant plans for assigned studies prior to study start
Review serious adverse events, SUSARs, safety reports and analyze similar cases
Support the clinical data management team with MedDRA and WHO drug coding
Review clinical study documents, including protocols, informed consent forms, clinical study reports and safety reports
Contribute to the setup and conduct of data safety monitoring boards and dose-escalation meetings
Participate in and present at study startup meetings, investigator meetings and other relevant meetings
Provide 24/7 on-call medical support for urgent medical issues
Train project teams on medical and therapeutic aspects of trials
Review protocol deviations
Identify study-related risks and contribute to the risk management plan
Review medical deliverables and contribute to budget tracking
Participate in therapeutic and drug development conferences, with potential presentations
Maintain effective communication and client relationships
Participate in client assessments, site visits and proposal presentations

Medical degree (MD)
Experience as an oncologist
Minimum of three years of relevant professional experience with strong expertise in oncology
Good knowledge of GxP standards
In good standing with local, provincial and national regulatory and licensing authorities and certifying bodies
Understanding of GDPR/HIPAA, CFR/CTR/CTD and applicable local regulatory requirements
Excellent written and verbal communication skills, including strong command of English
Presentable, outgoing and client-focused
Ability to work in the dynamic, fast-paced environment of a growing company
Strong administrative skills
Proficient in Word, Excel and PowerPoint

Comprehensive benefits package according to location
Competitive salary based on location
Departmental training and education budget to support professional development
Flexible working hours (within reason)
Remote or hybrid work options depending on location
Opportunities for leadership roles and mentorship
Participation in our buddy program, available to new hires and existing employees
Internal mobility and career advancement opportunities
Employee referral program with financial incentives
Access to online training for soft and technical skills via ADP and our internal platforms
Eligibility for our spot bonus program, rewarding exceptional project contributions
Eligibility for our long-service recognition program, acknowledging loyalty and commitment of long-tenured employees